ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy

Head and Neck Cancer Clinical Trial

Official title: A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy, of Which at Least One Line Must Be Systemic Therapy

Status Recruiting

Clinical Trial Summary

A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 vs Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy

Clinical Trial Description

The study will have an Experimental Arm and a Control Arm.

Experimental Arm:

Patients may receive repeated ASP-1929 PIT interventions for up to a maximum of 8 cycles within a period of up to 12 months after randomization until the patient has complete remission, progressive disease that is no longer amendable to study treatment, patient experiences intolerable side effects, or patient discontinues study treatment. Repeat ASP-1929 treatment cycles will be administered no less than 4 weeks from the previous ASP-1929 infusion.

Control Arm:

Patients may be treated with physician's choice standard of care until the patient has progressive disease, patient experiences intolerable side effects, discontinues study treatment, or chooses to withdraw. ;

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

• NCT number: NCT03769506
• Study type: Interventional
• Source: Rakuten Medical, Inc.
• Contact: Bogdan Veresh, MD
• Phone: 858-207-3113
• Email: clinicaltrialinfo@rakuten-med.com
• Status: Recruiting
• Phase: Phase 3
• Start date: May 9, 2019
• Completion date: December 30, 2024